Apparatus and method for sterilizing and assembling a cartridge containing a medical substance to a device for dispensing said medical substance

Abstract

An apparatus (4) for sterilizing and assembling a cartridge (8) containing a medical substance to a device (12) for dispensing said medical substance, comprising: a cartridge (8) containing the medical substance to be dispensed, the cartridge being provided with a cap (24), a device (12) for dispensing said medical substance, the device being provided with at least one needle (28) configured to pierce the cap (24) of the cartridge (8) and allow the withdrawal of the medical substance from the cartridge (8), a first interface (32) that may be sealingly joined to the cap (24) of the cartridge (8) by means of the interposition of a first gasket (36), a second interface (40) joined to the dispensing device (12) near said needle (28), wherein the second interface (40) has a seal (44) that isolates the needle (28) from the external environment in a sterile volume (48), and is provided with a second gasket (52) which may be sealingly joined to the first interface (32) in order to identify a sealed chamber (56) delimited between a portion of the cap (24) facing said needle (28) and said seal (44), the second gasket (52) being external to said sterile volume (48), and a sterilizing device (80) configured to irradiate and sterilize said sealed chamber (56).

1 . An apparatus for sterilizing and assembling a cartridge containing a medical substance to a device for dispensing said medical substance, comprising:
 a cartridge containing the medical substance to be dispensed, the cartridge being provided with a cap,   a device for dispensing said medical substance, which device is provided with at least one hollow needle configured to pierce the cap of the cartridge and allow the withdrawal of the medical substance from the cartridge, in order to dispense said substance,   a first interface that may be sealingly joined to the cap or to a portion of the cartridge,   a second interface joined to the dispensing device near said needle,   wherein the second interface has a seal that isolates the needle from the external environment in a sterile volume, and is provided with a second gasket which may be sealingly joined to the first interface or to the cartridge itself in order to identify a sealed chamber delimited between a portion of the cap facing said needle and said seal,   a sterilizing device configured to irradiate and sterilize said sealed chamber.   
     
     
         2 . The sterilization and assembly apparatus according to  claim 1 , wherein the first interface may be sealingly joined to the cap of the cartridge by means of the interposition of a first gasket, and wherein the second gasket is external to said sterile volume. 
     
     
         3 . The sterilization and assembly apparatus according to  claim 1 , wherein the first interface has a cylindrical, axial-symmetric configuration with respect to a main extension axis. 
     
     
         4 . The sterilization and assembly apparatus according to  claim 1 , wherein the first interface comprises a collar that is counter-shaped with respect to the cap. 
     
     
         5 . The sterilization and assembly apparatus according to  claim 4 , wherein the first interface comprises a first beaker comprised in the sealed chamber and suitable for interfacing with the second interface, wherein the first beaker has a narrowed section with respect to the collar. 
     
     
         6 . The sterilization and assembly apparatus according to  claim 1 , comprising, inside the sealed chamber, a first beaker configured to break the seal of the second interface when pressed against it. 
     
     
         7 . The sterilization and assembly apparatus according to  claim 1 , wherein the first interface is configured to break the seal of the second interface when pressed against it. 
     
     
         8 . The sterilization and assembly apparatus according to  claim 1 , wherein the seal is a film. 
     
     
         9 . The sterilization and assembly apparatus according to  claim 1 , wherein the apparatus comprises an end stop for the movement of the cartridge provided with the first interface towards the needle, said end stop being configured and positioned so as to stop the movement of the cartridge before the first beaker makes contact against the seal, wherein at the end stop there is hermetic contact between the first beaker and the second gasket. 
     
     
         10 . The sterilization and assembly apparatus according to  claim 9 , wherein said end stop stops the movement of the cartridge towards the needle before the latter pierces the cap and the seal. 
     
     
         11 . The sterilization and assembly apparatus according to  claim 9 , wherein the end stop is configured so as to allow an additional advance stroke of the cartridge towards the needle, so as to allow the penetration of the needle into the cap. 
     
     
         12 . The sterilization and assembly apparatus according to  claim 1 , wherein the second interface comprises a cylindrical widened section that forms a seat for said second gasket. 
     
     
         13 . The sterilization and assembly apparatus according to  claim 12 , wherein said cylindrical widened section is configured to form an end stop of the cartridge at a narrowed section of the first interface after the needle has pierced the cap. 
     
     
         14 . The sterilization and assembly apparatus according to  claim 1 , wherein the sterilizing device is configured to emit UV radiation and/or a sterilization beam. 
     
     
         15 . The sterilization and assembly apparatus according to  claim 1 , wherein the sterilizing device is configured to irradiate and sterilize only said sealed chamber or around it. 
     
     
         16 . The sterilization and assembly apparatus according to  claim 1 , comprising a mask suitable for being fitted around the cartridge near the cap or part of the cartridge or the device, said mask being impermeable to the radiation and/or the sterilizing beam emitted by the sterilizing device so as to protect the medical substance contained in said cartridge and/or the components of the dispensing device. 
     
     
         17 . The sterilization and assembly apparatus according to  claim 1 , wherein said sterilizing device is completely external to and separate from the cartridge and from the dispensing device. 
     
     
         18 . The sterilization and assembly apparatus according to  claim 1 , wherein the sterilization and assembly apparatus comprises means for moving the cartridge that are configured to move the cartridge and/or the needle towards one another, enabling the piercing of said seal and/or said cap. 
     
     
         19 . The sterilization and assembly apparatus according to  claim 1 , wherein said first interface and said second interface are configured so as to be at least partially permeable to the radiation and/or to the electrons emitted by the sterilizing device. 
     
     
         20 . The sterilization and assembly apparatus according to  claim 1 , wherein said first interface and said second interface are configured in such a way as to realize a mechanical coupling or mutual engagement, so as to mechanically fix the cartridge to the dispensing device near the needle of the latter. 
     
     
         21 . The sterilization and assembly apparatus according to  claim 1 , wherein the first interface and the second interface are in one piece so as to realize a single interface means that is fixed to the dispensing device and is suitable for sealingly housing the cartridge and/or the cap of said cartridge. 
     
     
         22 . A method for sterilizing and assembling a cartridge containing a medical substance to a device for dispensing said medical substance, comprising the steps of:
 providing a cartridge containing a medical substance to be dispensed, the cartridge being provided with a cap,   providing a device for dispensing said medical substance, which device is provided with at least one needle configured to pierce the cap of the cartridge and allow the withdrawal of the medical substance from the cartridge,   providing a first interface and sealingly joining it to the cap of the cartridge by means of the interposition of a first gasket,   providing a second interface provided with a second gasket and sealingly joining it to the dispensing device near said needle, the second interface being provided with a seal that isolates the needle from the external environment inside a sterile volume, the second gasket being external to said sterile volume,   sealingly joining the first interface to the second interface in order to create a sealed chamber between the seal and the first interface, said sealed chamber housing a portion of the cap facing said needle,   providing a sterilizing device configured to irradiate and sterilize said sealed chamber.   
     
     
         23 . The sterilization and assembly method according to  claim 22 , comprising the step of moving the cartridge and the needle towards one another so as to pierce the seal with the first interface after having sterilized the sealed chamber, without letting the needle penetrate the cap, in the condition of non-use of the dispensing device or ‘primary packaging’. 
     
     
         24 . The sterilization and assembly method according to  claim 23 , comprising the step of moving the cartridge and the needle towards one another so as to pierce the cap with the needle in the condition of use or dispensing the medical substance using the dispensing device. 
     
     
         25 . The sterilization and assembly method according to  claim 22 , comprising the step of providing a mask suitable for being fitted around the cartridge near the cap, said mask being impermeable to the radiation and/or to the electron beam emitted by the sterilizing device so as to protect the medical substance contained in said cartridge during the step of sterilizing the sealed chamber. 
     
     
         26 . The sterilization and assembly method according to  claim 22 , wherein the step of sterilizing the sealed chamber is carried out by means of said sterilizing device external to and separate from the cartridge and also from the dispensing device. 
     
     
         27 . The sterilization and assembly method according to  claim 22 , wherein the first interface and the second interface are in one piece so as to realize a single interface means that is fixed to the dispensing device and sealingly houses the cartridge and/or the cap of said cartridge.